check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
11139
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Assessment of efficacy of vardenafil, influence on self-esteem and self-confidence in subjects with erectile dysfunction
Trial purpose
Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.
Key Participants Requirements
Sex
MaleAge
18 YearsTrial summary
Enrollment Goal
129Trial Dates
May 2003 - January 2004Phase
Phase 3Could I Receive a placebo
YesProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Málaga, 29010, Spain | |
Completed | Valladolid, 47011, Spain | |
Completed | Móstoles, 28935, Spain | |
Completed | Alicante, 03010, Spain | |
Completed | Oviedo, 33006, Spain | |
Completed | Barcelona, 08025, Spain | |
Completed | Sevilla, 41071, Spain | |
Completed | Valencia, 46014, Spain | |
Completed | Sabadell, 08208, Spain | |
Completed | Vigo, 36211, Spain | |
Completed | Hondarribia, 28280, Spain | |
Withdrawn | Leganés, 28911, Spain | |
Completed | Granada, 18003, Spain |
Primary Outcome
- International Index of Erectile Function - Erectile Function Domaindate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Global Assessment Questionnairedate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- IIEF-EF domain scoredate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- Other diary based variablesdate_rangeTime Frame:12 weeksenhanced_encryptionnoSafety Issue:
- Safety and tolerabilitydate_rangeTime Frame:12 weeksenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2